TWIHL: Innovation and Protection: The Future of Medical Device Regulation, Episode 1
The first of three episodes of “Innovation and Protection: The Future of Medical Device Regulation” looks at big-picture issues in the U.S.
Pharmaceuticals
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Read more: TWIHL: Innovation and Protection: The Future of Medical Device Regulation, Episode 1 -
Read more: To Address COVID-19 Disparities, 340B Hospitals Need More Flexibility To Address COVID-19 Disparities, 340B Hospitals Need More Flexibility
Increased flexibility for 340B covered entities is necessary to address COVID-19 disparities faced by marginalized communities.
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Read more: Racial Disparities Persist in Human Subjects Research Racial Disparities Persist in Human Subjects Research
Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Topics include the association between the clinical benefit of cancer drugs and their prices, and whether to include children in COVID-19 therapy trials.
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Read more: How Do We Arrive at Fair Pricing for COVID-19 Therapies? How Do We Arrive at Fair Pricing for COVID-19 Therapies?
As the search for COVID-19 treatments and vaccines continues, questions of pricing and access are beginning to emerge.
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Read more: New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs
Pandemics like COVID-19 certainly require the prompt approval of treatments, but efficacy and safety should not come at the cost of speed.
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Read more: Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation
Over a decade after being recalled, rofecoxib received orphan drug designation for the treatment of pain caused by hemophilic arthropathy.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
The selections feature topics ranging from increases in Internet searches for hydroxychloroquine following promotional remarks by the president, to an evaluation of health gains from orphan drugs to an assessment of clinical trials supporting new FDA drug approvals.
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Read more: Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson
In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Topics include off-label and compassionate drug use for COVID-19 and utilization and cost of naloxone for patients at high risk of opioid overdose.
